Durbin Introduces Legislation To Improve Safety And Ensure Transparency Of Dietary Supplements

9 Out Of 10 American Adults Support Listing Requirements For Dietary Supplements

WASHINGTON – U.S. Senate Majority Whip Dick Durbin (D-IL) today introduced the Dietary Supplement Listing Act of 2024, legislation to require dietary supplement manufacturers to list their products with the Food and Drug Administration (FDA). In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which provided FDA with authorities to regulate dietary supplements. However, DSHEA did not require dietary supplement companies to register their products with FDA, leaving the agency without the much-needed information to properly understand or oversee the market. In 1994, there were 4,000 dietary supplements marketed in the United States. Today, FDA estimates there are more than 100,000 on the market.

“FDA—and consumers—should know what dietary supplements are on the market and what ingredients are included in them. This is FDA’s most basic function, and the first step to protecting consumers,” said Durbin, “There are more than one hundred thousand products on the market, but we don’t know critical information about most of them. Americans deserve a transparent supplement market, and it’s past time that we deliver it for them.”

The Dietary Supplement Listing Act of 2024 would require companies to provide FDA with critical information about their products, including product names; a list of all ingredients; an electronic copy of the label; allergen statements; health and structure/function claims; and more. This information would be made public to Americans through an electronic database.

More than 75 percent of American adults use a dietary supplement. However, no product is without risk. In 2023, FDA received more than 2,000 adverse event reports related to dietary supplements. However, due to significant underreporting, FDA has estimated the actual annual number of adverse events is more than 50,000. Over the last 30 years, annual dietary supplement sales increased from $4 billion to more than $50 billion.

Durbin’s introduction of the Dietary Supplement Listing Act of 2024 comes after he introduced the Prohibiting Tianeptine and Other Dangerous Products Act in April, which would prohibit illegal or otherwise dangerous ingredients, such as tianeptine, from being included in products marketed as dietary supplements.

Tianeptine is an unapproved drug that is marketed as a purported dietary supplement and sold under labels such as “Neptune’s Fix.” Ingestion of the drug has led to an increase in calls to poison control centers and severe adverse effects requiring visits to emergency rooms nationwide. According to America’s Poison Control Centers, 391 tianeptine cases were reported nationwide last year. House Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ-06) introduced companion legislation in the House.